🏛️ Verified NIH Record • Updated 2026-08-03

L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML (NCT06788756)

A Pivotal Phase 2/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of L Annamycin for Injection in Combination With Cytarabine Injection Versus Placebo in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed Acute Myeloid Leukemia

🟢 Recruiting Phase2 / Phase3 💊 Investigational Drug / Biologic Sponsor: Moleculin Biotech, Inc.

🩺 Plain-English Summary (8th-Grade Level)

This pivotal phase 2/3, multi-center, adaptive design study of L-Annamycin for Injection in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML is divided into two parts, Part A and Part B.

Who can join: Review the eligibility criteria below.

Location: University of Alabama Birmingham — Birmingham, Alabama

Age range: 18 Years to 80 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (28 Sites)

Showing the first 25 of 28 sites.

  • University of Alabama Birmingham — Birmingham, Alabama
  • Bioresearch Partners — Miami, Florida
  • Augusta University - Georgia Cancer Center — Augusta, Georgia
  • University of Nebraska Medical Center — Omaha, Nebraska
  • Atlantic Health — Morristown, New Jersey
  • University Hospitals Cleveland Medical Center — Cleveland, Ohio
  • University of Pennsylvania — Philadelphia, Pennsylvania
  • University of Rhode Island — Providence, Rhode Island
  • Fakultní nemocnice Hradec Králové — Hradec Králové,
  • GEORGIA: LLC ARENSIA Exploratory Medicine — Tbilisi,
  • Caucasus Medical Center — Tbilisi,
  • RCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia — Bologna,
  • AOU Careggi — Florence,
  • AUSL della Romagna - Santa Maria delle Croci - Ravenna — Ravenna,
  • Fondazione Policlinico Universitario A. Gemelli IRCCS, Catholic University of the Sacred Heart — Roma,
  • LSMU Kauno klinikos — Kaunas,
  • Szpital Kliniczny MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie Oddział Kliniczny Hematologii i Chorób Wewnętrznych z Ośrodkiem Transplantacji Szpiku — Olsztyn,
  • Oddział Hematologii i Transplantacji Szpiku, Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan,
  • Uniwersytecki Szpital Kliniczny Klinika Hematologii i Transplantologii (Szczecin) — Szczecin,
  • Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Oddział Hematologii — Torun,
  • Instytut Hematologii i Transfuzjologii, Klinika Hematologii — Warsaw,
  • ARENSIA research clinic at the Oncology Institute "Prof. Dr. Ion Chiricuţă" — Cluj-Napoca,
  • Institut Català d'Oncología (ICO) - Hospital Germans Trias i Pujol — Barcelona, Badalona
  • Hospital Universitario Central de Asturias (HUCA) — Oviedo, Principality of Asturias
  • Hospital MD Anderson Cancer Center Madrid — Madrid,

📞 Contact the Study Coordinator

Phone: (202) 760-1378

Email: pwaymack@moleculin.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗